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Last Updated: March 19, 2024

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - Generic Drug Details


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What are the generic drug sources for dextromethorphan hydrobromide; guaifenesin and what is the scope of patent protection?

Dextromethorphan hydrobromide; guaifenesin is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Perrigo R And D, Sun Pharm, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Sixty-one suppliers are listed for this compound.

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MUCINEX DM Extended-release Tablets dextromethorphan hydrobromide; guaifenesin 600 mg/30 mg and 1200 mg/60 mg 021620 1 2008-12-17

US Patents and Regulatory Information for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 207602-001 Mar 5, 2018 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 207602-002 Mar 5, 2018 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 217340-002 Aug 1, 2023 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 214781-001 Jul 1, 2021 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 091070-002 Aug 31, 2015 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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